AgingCOmPLETENCT03986892
The COmPLETE Study
An observational study of Aging and Heart Failure, run by Arno Schmidt-Trucksäss at 1 site in Switzerland.
Trial summary
The project is designed as a large scale, cross-sectional study. This research seeks to identify physical fitness and cardiovascular parameters that best resemble underlying cardiovascular risk with age. Further, it will examine which physical fitness markers are impaired most in heart failure. Read more about this study
- Who is it for?
- Ages 20 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Heart Failure
- What is being tested?
- Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 678 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Jan 2018to 31 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: In C-Health, recruitment will be performed until a total number of 490 participants with a valid cardiopulmonary exercise test (CPET) as our primary outcome are included. All participants will be recruited in the area of Basel, including 35 males and 35 females per age category (i.e., 20-29, 30-39, 40-49, 50-59, 60-69, 70-79, and 80+ years of age). C-Heart will include 80 heart failure patients characterized according to criteria named below. Stable CHF (treated patient with symptoms and signs that have remained generally unchanged for at least one month) characterized according to the European Society of Cardiology guidelines for the diagnosis and treatment of acute and chronic heart failure [82], as follows: 1. HFrEF (LVEF < 40%) 2. HFmHF (LVEF 40-49%) 3. HFpEF (LVEF ≥ 50%) and NT-proBNP > 125 pg/mL and structural or functional changes in echocardiography in no. 2 or 3.
Who may be able to join
- C-Health:
- Healthy men and women aged 20-100 years
- Body mass index < 30 kg/m2
- Nonsmoker
- C-Heart:
- Stable CHF (treated patient with symptoms and signs that have remained generally unchanged for at least one month) characterized according to the European Society of Cardiology guidelines for the diagnosis and treatment of acute and chronic heart failure [82], as follows:
Show all 9Show fewer
- HFrEF (LVEF < 40%)
- HFmHF (LVEF 40-49%)
- HFpEF (LVEF ≥ 50%) and NT-proBNP > 125 pg/mL and structural or functional changes in echocardiography in no. 2 or 3.
Who cannot join
- C-Health:
- Age younger than 20 years; manifest exercise limiting chronic disease (e.g., myocardial infarction; stroke; heart failure; lower-extremity artery disease; cancer with general symptoms; diabetes; clinically apparent renal failure; severe liver disease; chronic bronchitis GOLD stages II to IV; osteoporosis), women with known pregnancy or breastfeeding; drug or alcohol abuse; hypertonic blood pressure of less than 160/100 mmHg; compromising orthopaedic problems; Alzheimer's disease or any other form of dementia; inability to follow the procedures of the study (e.g., due to language problems, psychological disorders, dementia of the participant); diseases regarded as an absolute contraindication for maximal exertion; and current or past smoking status.
- C-Heart:
- Age younger than 20 years; women with known pregnancy or breastfeeding; drug or alcohol abuse; inability to follow the study procedures (e.g., due to language problems, psychological disorders, etc.); unstable angina pectoris; uncontrolled brady- or tachyarrythmia; paroxysmal atrial fibrillation; severe uncorrected valvular disease; acute myocardial infarction or coronary syndrome; transient ischemic attack or stroke occurring less than three months prior; clinically significant concomitant disease states (e.g. uncontrolled hypertonic blood pressure); clinical evidence of current malignancy with exception of basal cell or squamous cell carcinoma of the skin and/or cervical intraepithelial neoplasia; currently receiving systemic chemotherapy and/or radiotherapy; significant musculoskeletal disease other than that associated with heart failure limiting exercise tolerance; active infection; immunosuppressive medical therapy; life-expectancy of less than six months; and prevalence of a disease regarded as an absolute contraindication for maximal exertion.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department for Sport, Exercise and Health, Section Sports and Exercise Medicine, University of Basel
Basel, 4052
About this study
Official title: Functional Aging in Health and Heart Failure: The COmPLETE Study
The project is designed as a large scale, cross-sectional study. This research seeks to identify physical fitness and cardiovascular parameters that best resemble underlying cardiovascular risk with age. Further, it will examine which physical fitness markers are impaired most in heart failure.
Read the detailed description
Cardiovascular (CV) diseases including heart failure are the leading causes of morbidity, with age being the primary risk factor. The combination of age-related organic functional impairment and reduced physical fitness can drastically impact an individual's healthspan. One's lifespan can potentially be prolonged by the preservation or improvement of physical fitness. However, it remains unclear as to which biomarkers are most suitable for distinguishing between healthy aging and the impaired organ function associated with heart failure. Therefore, a comprehensive assessment of the components of physical fitness and CV function will be performed to identify the most important factors contributing to aging in relation to both health and disease.
This cross-sectional investigation will consist of two parts: the COmPLETE-Health (C-Health) and COmPLETE-Heart (C-Heart) studies. C-Health will examine the aging trajectories of physical fitness components and CV properties in a healthy population sample aged between 20 and 100 years (n = 490). Separately, C-Heart will assess the same markers in patients at different stages of chronic heart failure (n = 80). The primary outcome to determine the difference between C-Health and C-Heart will be cardiorespiratory fitness as measured by cardiopulmonary exercise testing on a bicycle ergometer. Secondary outcomes will include walking speed, balance, isometric strength, peak power, and handgrip strength. Physical activity as a behavioural component will be assessed objectively via accelerometry. Further, CV assessments will include pulse wave velocity; retinal, arterial, and venous diameters; brachial and retinal arterial endothelial function; carotid intima-media thickness; and systolic and diastolic function. The health distances for C-Health and C-Heart will be calculated using the methodology based on statistical (Mahalanobis) distance applied to measurements of quantitative biomarkers.
This research seeks to identify physical fitness and CV biomarkers that best resemble underlying CV risk with age. Further, it will examine which physical fitness markers are impaired most in heart failure. The presented integrative approach could define new recommendations for diagnostic guidance in aging. Ultimately, this study is expected to offer a better understanding of which functional characteristics should be specifically targeted in primary and secondary prevention to achieve an optimal healthspan.
- Conditions
- Aging, Heart Failure
- Being tested
- Physical Activity
- Keywords
- fitness, exercise, vascular function
- Medical subject headings
- Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
Physical Activity
| Study group | Role | What they receive |
|---|---|---|
| COmPLETE-Health | No intervention Receives: Behavioral: Physical Activity | |
| COmPLETE-Heart | No intervention Receives: Behavioral: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratroy Fitness
Maximal Oxygen uptake measured by cardiopulmonary exercise testing (VO2peak) in L/min
Measured: 3 hours after inclusion in study
Ventilatory Efficiency
VE/VCO2 measured by cardiopulmonary exercise testing ((L/min)/(L/min))
Measured: 3 hours after inclusion in study
Oxygen Uptake Efficiency
The Oxygen Uptake Efficiency Slope is defined as the regression slope 'a' in V̇O2 = a × log VE +b measured by cardiopulmonary exercise testing.
Measured: 3 hours after inclusion in study
Gait speed
Gait speed measured by an inertial sensor system in m/s.
Measured: 1.5 hours after inclusion in study
Standing balance
The cumulative sway path (cm) serves as a measure of postural control.
Measured: 2.5 hours after inclusion in study
Hand grip strength
Measured by a handheld dynamometer. Maximal achieved grip strength (kg) is recorded.
Measured: 2.5 hours after inclusion in study
Power of leg muscles
Peak power measured by countermovement jump performed on a force plate. Reported in N/kg
Measured: 2.5 hours after inclusion in study
Arterial stiffness
Meausred by an noninvasive vascular screening system. Reported as brachial-ankle pulse wave velocity (baPWV).
Measured: 0.5 hours after inclusion in study
Endothelial function
Meausred as flow mediated dilation (FMD) by ultrasound reported as %.
Measured: 1 hours after inclusion in study
Left ventricular ejection fraction
Meausred by echocardiography reported as %.
Measured: 1 hour after inclusion in study
Carotid-intima-media thickness
Carotid intima-media thickness (mm) is measured by 2D ultrasound instrument.
Measured: 1 hour after inclusion in study
Retinal arterial and venous diameters
Measured by static retinal vessel analysis. Diameters will be averaged to central retinal arteriolar and venular equivalents (CRAE and CRVE) and the arteriolar-to-venular diameter ratio will be calculated from the CRAE and CRVE.
Measured: 7-30 days after inclusion in study
Retinal endothelial function
Measured by dynamic retinal vessel analysis reported as %.
Measured: 7-30 days after inclusion in study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start3 Jan 2018
- Primary completion20 Dec 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 678 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arno Schmidt-Trucksäss
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Arno Schmidt-Trucksäss, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986892
- Sponsor's protocol ID
- 182815
- Acronym
- COmPLETE
- Status last verified
- Apr 2020
- First submitted
- 5 Jun 2019
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schwendinger F, Knaier R, Wagner J, Infanger D, Lichtenstein E, Hinrichs T, Rowlands A, Schmidt-Trucksass A. Relative and absolute intensity accelerometer metrics decipher the effects of age, sex, and occupation on physical activity. BMC Public Health. 2025 Mar 6;25(1):885. doi: 10.1186/s12889-025-21800-w.
PubMed 40050804Prechtl L, Carrard J, Gallart-Ayala H, Borreggine R, Teav T, Konigstein K, Wagner J, Knaier R, Infanger D, Streese L, Hinrichs T, Hanssen H, Ivanisevic J, Schmidt-Trucksass A. Circulating amino acid signature features urea cycle alterations associated with coronary artery disease. Sci Rep. 2024 Oct 28;14(1):25848. doi: 10.1038/s41598-024-76835-7.
PubMed 39468229Schwendinger F, Wagner J, Knaier R, Infanger D, Rowlands AV, Hinrichs T, Schmidt-Trucksass A. Accelerometer Metrics: Healthy Adult Reference Values, Associations with Cardiorespiratory Fitness, and Clinical Implications. Med Sci Sports Exerc. 2024 Feb 1;56(2):170-180. doi: 10.1249/MSS.0000000000003299. Epub 2023 Sep 12.
PubMed 37703330Schwendinger F, Wagner J, Infanger D, Schmidt-Trucksass A, Knaier R. Methodological aspects for accelerometer-based assessment of physical activity in heart failure and health. BMC Med Res Methodol. 2021 Nov 14;21(1):251. doi: 10.1186/s12874-021-01350-6.
PubMed 34775952Streese L, Vaes A, Infanger D, Roth R, Hanssen H. Quantification of Retinal Vessel Myogenic Constriction in Response to Blood Pressure Peaks: Implications for Flicker Light-Induced Dilatation. Front Physiol. 2021 Feb 18;12:608985. doi: 10.3389/fphys.2021.608985. eCollection 2021.
PubMed 33679432
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Aging in Health and Heart Failure: The COmPLETE Study
- ClinicalTrials.gov ID
- NCT03986892
- Acronym / sponsor ID
- COmPLETE / 182815
- Conditions
- Aging, Heart Failure
- Keywords
- fitness, exercise, vascular function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 678 participants (actual)
- Lead sponsor
- Arno Schmidt-TrucksässUniversity, hospital or other
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 14 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project is designed as a large scale, cross-sectional study. This research seeks to identify physical fitness and cardiovascular parameters that best resemble underlying cardiovascular risk with age. Further, it will examine which physical fitness markers are impaired most in heart failure.
Detailed description
Cardiovascular (CV) diseases including heart failure are the leading causes of morbidity, with age being the primary risk factor. The combination of age-related organic functional impairment and reduced physical fitness can drastically impact an individual's healthspan. One's lifespan can potentially be prolonged by the preservation or improvement of physical fitness. However, it remains unclear as to which biomarkers are most suitable for distinguishing between healthy aging and the impaired organ function associated with heart failure. Therefore, a comprehensive assessment of the components of physical fitness and CV function will be performed to identify the most important factors contributing to aging in relation to both health and disease.
This cross-sectional investigation will consist of two parts: the COmPLETE-Health (C-Health) and COmPLETE-Heart (C-Heart) studies. C-Health will examine the aging trajectories of physical fitness components and CV properties in a healthy population sample aged between 20 and 100 years (n = 490). Separately, C-Heart will assess the same markers in patients at different stages of chronic heart failure (n = 80). The primary outcome to determine the difference between C-Health and C-Heart will be cardiorespiratory fitness as measured by cardiopulmonary exercise testing on a bicycle ergometer. Secondary outcomes will include walking speed, balance, isometric strength, peak power, and handgrip strength. Physical activity as a behavioural component will be assessed objectively via accelerometry. Further, CV assessments will include pulse wave velocity; retinal, arterial, and venous diameters; brachial and retinal arterial endothelial function; carotid intima-media thickness; and systolic and diastolic function. The health distances for C-Health and C-Heart will be calculated using the methodology based on statistical (Mahalanobis) distance applied to measurements of quantitative biomarkers.
This research seeks to identify physical fitness and CV biomarkers that best resemble underlying CV risk with age. Further, it will examine which physical fitness markers are impaired most in heart failure. The presented integrative approach could define new recommendations for diagnostic guidance in aging. Ultimately, this study is expected to offer a better understanding of which functional characteristics should be specifically targeted in primary and secondary prevention to achieve an optimal healthspan.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COmPLETE-Health | – | Behavioral: Physical ActivityNo intervention |
| COmPLETE-Heart | – | Behavioral: Physical ActivityNo intervention |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In C-Health, recruitment will be performed until a total number of 490 participants with a valid cardiopulmonary exercise test (CPET) as our primary outcome are included. All participants will be recruited in the area of Basel, including 35 males and 35 females per age category (i.e., 20-29, 30-39, 40-49, 50-59, 60-69, 70-79, and 80+ years of age). C-Heart will include 80 heart failure patients characterized according to criteria named below. Stable CHF (treated patient with symptoms and signs that have remained generally unchanged for at least one month) characterized according to the European Society of Cardiology guidelines for the diagnosis and treatment of acute and chronic heart failure [82], as follows: 1. HFrEF (LVEF < 40%) 2. HFmHF (LVEF 40-49%) 3. HFpEF (LVEF ≥ 50%) and NT-proBNP > 125 pg/mL and structural or functional changes in echocardiography in no. 2 or 3.
Key inclusion criteria (9 listed)
- Healthy men and women aged 20-100 years
- Body mass index < 30 kg/m2
- Nonsmoker
- Stable CHF (treated patient with symptoms and signs that have remained generally unchanged for at least one month) characterized according to the European Society of Cardiology guidelines for the diagnosis and treatment of acute and chronic heart failure [82], as follows:
Key exclusion criteria (4 listed)
- Age younger than 20 years; manifest exercise limiting chronic disease (e.g., myocardial infarction; stroke; heart failure; lower-extremity artery disease; cancer with general symptoms; diabetes; clinically apparent renal failure; severe liver disease; chronic bronchitis GOLD stages II to IV; osteoporosis), women with known pregnancy or breastfeeding; drug or alcohol abuse; hypertonic blood pressure of less than 160/100 mmHg; compromising orthopaedic problems; Alzheimer's disease or any other form of dementia; inability to follow the procedures of the study (e.g., due to language problems, psychological disorders, dementia of the participant); diseases regarded as an absolute contraindication for maximal exertion; and current or past smoking status.
- Age younger than 20 years; women with known pregnancy or breastfeeding; drug or alcohol abuse; inability to follow the study procedures (e.g., due to language problems, psychological disorders, etc.); unstable angina pectoris; uncontrolled brady- or tachyarrythmia; paroxysmal atrial fibrillation; severe uncorrected valvular disease; acute myocardial infarction or coronary syndrome; transient ischemic attack or stroke occurring less than three months prior; clinically significant concomitant disease states (e.g. uncontrolled hypertonic blood pressure); clinical evidence of current malignancy with exception of basal cell or squamous cell carcinoma of the skin and/or cervical intraepithelial neoplasia; currently receiving systemic chemotherapy and/or radiotherapy; significant musculoskeletal disease other than that associated with heart failure limiting exercise tolerance; active infection; immunosuppressive medical therapy; life-expectancy of less than six months; and prevalence of a disease regarded as an absolute contraindication for maximal exertion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ActivityPhysical Activity | Behavioural | COmPLETE-Health, COmPLETE-Heart |
Primary outcome
Cardiorespiratroy Fitness
Time frame: 3 hours after inclusion in study
Maximal Oxygen uptake measured by cardiopulmonary exercise testing (VO2peak) in L/min
Ventilatory Efficiency
Time frame: 3 hours after inclusion in study
VE/VCO2 measured by cardiopulmonary exercise testing ((L/min)/(L/min))
Oxygen Uptake Efficiency
Time frame: 3 hours after inclusion in study
The Oxygen Uptake Efficiency Slope is defined as the regression slope 'a' in V̇O2 = a × log VE +b measured by cardiopulmonary exercise testing.
Gait speed
Time frame: 1.5 hours after inclusion in study
Gait speed measured by an inertial sensor system in m/s.
Standing balance
Time frame: 2.5 hours after inclusion in study
The cumulative sway path (cm) serves as a measure of postural control.
Hand grip strength
Time frame: 2.5 hours after inclusion in study
Measured by a handheld dynamometer. Maximal achieved grip strength (kg) is recorded.
Power of leg muscles
Time frame: 2.5 hours after inclusion in study
Peak power measured by countermovement jump performed on a force plate. Reported in N/kg
Arterial stiffness
Time frame: 0.5 hours after inclusion in study
Meausred by an noninvasive vascular screening system. Reported as brachial-ankle pulse wave velocity (baPWV).
Endothelial function
Time frame: 1 hours after inclusion in study
Meausred as flow mediated dilation (FMD) by ultrasound reported as %.
Left ventricular ejection fraction
Time frame: 1 hour after inclusion in study
Meausred by echocardiography reported as %.
Carotid-intima-media thickness
Time frame: 1 hour after inclusion in study
Carotid intima-media thickness (mm) is measured by 2D ultrasound instrument.
Retinal arterial and venous diameters
Time frame: 7-30 days after inclusion in study
Measured by static retinal vessel analysis. Diameters will be averaged to central retinal arteriolar and venular equivalents (CRAE and CRVE) and the arteriolar-to-venular diameter ratio will be calculated from the CRAE and CRVE.
Retinal endothelial function
Time frame: 7-30 days after inclusion in study
Measured by dynamic retinal vessel analysis reported as %.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Derived from this study: PubMed 40050804Schwendinger F, Knaier R, Wagner J, Infanger D, Lichtenstein E, Hinrichs T, Rowlands A, Schmidt-Trucksass A. Relative and absolute intensity accelerometer metrics decipher the effects of age, sex, and occupation on physical activity. BMC Public Health. 2025 Mar 6;25(1):885. doi: 10.1186/s12889-025-21800-w.
- Derived from this study: PubMed 39468229Prechtl L, Carrard J, Gallart-Ayala H, Borreggine R, Teav T, Konigstein K, Wagner J, Knaier R, Infanger D, Streese L, Hinrichs T, Hanssen H, Ivanisevic J, Schmidt-Trucksass A. Circulating amino acid signature features urea cycle alterations associated with coronary artery disease. Sci Rep. 2024 Oct 28;14(1):25848. doi: 10.1038/s41598-024-76835-7.
- Derived from this study: PubMed 37703330Schwendinger F, Wagner J, Knaier R, Infanger D, Rowlands AV, Hinrichs T, Schmidt-Trucksass A. Accelerometer Metrics: Healthy Adult Reference Values, Associations with Cardiorespiratory Fitness, and Clinical Implications. Med Sci Sports Exerc. 2024 Feb 1;56(2):170-180. doi: 10.1249/MSS.0000000000003299. Epub 2023 Sep 12.
- Derived from this study: PubMed 34775952Schwendinger F, Wagner J, Infanger D, Schmidt-Trucksass A, Knaier R. Methodological aspects for accelerometer-based assessment of physical activity in heart failure and health. BMC Med Res Methodol. 2021 Nov 14;21(1):251. doi: 10.1186/s12874-021-01350-6.
- Derived from this study: PubMed 33679432Streese L, Vaes A, Infanger D, Roth R, Hanssen H. Quantification of Retinal Vessel Myogenic Constriction in Response to Blood Pressure Peaks: Implications for Flicker Light-Induced Dilatation. Front Physiol. 2021 Feb 18;12:608985. doi: 10.3389/fphys.2021.608985. eCollection 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Heart Failure, run by Arno Schmidt-Trucksäss at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratroy Fitness (time frame: 3 hours after inclusion in study). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03986892, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.